SCIENCE
REDEFINING THE FUTURE OF CAR T
Allogene is working to overcome the limitations of autologous CAR T therapies by creating investigational allogeneic CAR T cell products, or AlloCAR T™ products. Unlike autologous cell therapy, AlloCAR T™ products use T cells from healthy donors.
These cells are isolated in a manufacturing facility, engineered to express CARs to recognize and destroy disease, and modified via gene editing to limit autoimmune response when given to a patient. These products are then stored for "off-the-shelf" use on demand. We believe that, at scale, a single manufacturing run has the potential to yield treatment for 100+ patients.
Doing What No Autologous Treatment Has Done Before
ACCESS
- Potential to treat all eligible patients
- No need for complex logistics
COST
- Scalable and efficient manufacturing
- Potential to treat 100+ patients from a single manufacturing run
- Lower ancillary costs
SPEED/RELIABILITY
- "Off-the-shelf" for on-demand treatment
- Less product variability, made from healthy T cells
INNOVATION
- Multiplex
gene-engineering and gene-editing capabilities - Opportunity for product optimization
The next revolution in cell therapy is the development of AlloCAR T™ products engineered from the T cells of healthy donors. These "off-the-shelf" CAR T products, enhanced by gene editing, could be the next most important breakthrough in the field.
THE DIFFERENCE STARTS WITH HEALTHY DONORS
AlloCAR T™ PRODUCTS HAVE THE POTENTIAL TO TREAT PATIENTS IN DAYS
Source: Allogene data on file.
ALLOGENE IS CREATING THE AlloCAR T™ PRODUCT PLATFORM FOR TOMORROW
ALLO-329 in Autoimmune
- Next-generation AlloCAR T™ product to address both B cell and T cell dysfunction in autoimmune diseases
- Reduce or eliminate lymphodepletion to remove a key barrier of CAR T in autoimmune indications
- Q1 2025 IND with proof-of-concept by YE 2025
Cema-cel in 1L Consolidation LBCL
- Pivotal Ph2 ALPHA3 initiated June 2024; progress proceeding as planned
- Boost earlier line cure rates, make CAR T easily accessible at community cancer centers, and render later-line Tx obsolete
- LD selection mid-2025; Data expected 2026; BLA submission targeted 2027
ALLO-316 in RCC
- Leverage the Dagger® technology
to advance AlloCAR T™ product into the most elusive frontier—Solid Tumor - Ph1 TRAVERSE trial ongoing; Data readout presented at SITC and IKCS 2024
The Source: Scale for Future Demand at Cell Forge 1
Strategically leverage a wholly owned, state-of-the-art AlloCAR T™ product manufacturing facility
Cema-cel in 1L Consolidation LBCL
- Potentially boosting cure rates in frontline and rendering later-line treatment obsolete
- Make cema-cel available in community cancer centers where most earlier line patients seek care
Cema-cel in r/r CLL
- Capture the growing unmet medical need in CLL post-BTKi/BCL2i
- Address T cell dysfunction in CLL with healthy-donor derived AlloCAR T™ product
ALLO-329 in Autoimmune
- Next-generation AlloCAR T™ product to address both B cell and T cell dysfunction in autoimmune disease
- Aims to reduce or eliminate lymphodepletion, removing a key barrier to CAR T in autoimmune indications
ALLO-316 in RCC
- Leverage the Dagger® technology to advance AlloCAR T™ product into the most elusive frontier - Solid Tumor
TurboCAR™ TECHNOLOGY: TURBOCHARGING CAR T CELLS
- TurboCAR™ Technology is designed to recapitulate cytokine signaling selectively in CAR T
– Does not stimulate host immune cells which could cause systemic toxicity or reject CAR
– Delivers survival benefit selectively to CAR T cells - Opportunities for development include
– Improving the efficacy of CAR T cells
– Reducing CAR T cell dose requirement
– Overcoming exhaustion to enable CAR T to be used for solid tumors - Improved engraftment and persistence and delayed exhaustion seen preclinical studies
ELIMINATION OF TCR IN DONOR T CELLS MAY CONTROL GvHD
ALLO-647: SELECTIVE LYMPHODEPLETION MAY DELAY GRAFT REJECTION
Host T Cell Recovery Delayed by Addition of Anti-CD52
STATE-OF-THE-ART, IN-HOUSE MANUFACTURING FOR ON-DEMAND AlloCAR T™ PRODUCT AVAILABILITY
Maintaining state-of-the-art, world-class manufacturing capabilities is at the core of our strategy to deliver readily available cell products faster, more reliably, and at greater scale. Our manufacturing facility, Cell Forge 1, located in Newark, California, in the eastern region of the San Francisco Bay Area, is designed for clinical and commercial manufacturing, analytical testing and distribution of cell products. This facility provides in-house quality assurance and quality control, per current good manufacturing practices (cGMPs), to ensure a reliable supply of AlloCAR T™ products for our clinical programs and commercial products, pending regulatory approval.
MODULAR, FLEXIBLE DESIGN
Our modular, 136,000 square-foot facility was designed for growth. It currently has three production suites, with the ability to accommodate five as we look ahead to bringing new therapies onto the market.
IN-HOUSE QUALITY CONTROL AND TESTING
We believe in the critical importance of understanding the quality of our investigational AlloCAR T™ products, which is why we operate the entire scope of product testing and maintain an open data strategy in-house.
COMMITMENT TO SUSTAINABILITY
Cell Forge 1 is a carbon-free facility that is fully powered by electricity, much of which will be delivered by the 2,400 solar panels on the rooftop. CF1 received LEEDv4 Interior Design and Construction Gold certification.
COLLABORATIVE DESIGN
We included large windows throughout the facility to promote a culture of transparency and connection. Open workspaces, as well as the facility’s proximity to Allogene’s Headquarters, allow for regular cross-functional collaboration.